Ultrasound Probe Cover Biopsy Needle Guide Kit - Disposable Probe Cover Accessories - ADVANCE MEDICAL DESIGNS, INC.

Duns Number:130785884

Device Description: Disposable Probe Cover Accessories

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More Product Details

Catalog Number

-

Brand Name

Ultrasound Probe Cover Biopsy Needle Guide Kit

Version/Model Number

28-EG203

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K011265,K011265

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

2f8e20a1-0552-46b0-8282-b05cedbaf924

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Additional Identifiers

Package DI Number

10848340017558

Quantity per Package

10

Contains DI Package

00848340017551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ADVANCE MEDICAL DESIGNS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 619
U Unclassified 3